Johnson & Johnson (J&J) is seeking approvals for a new indication of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in the US and the subcutaneous (SC) formulation of Darzalex in the European Union (EU).
In this regard, the pharma major has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve these treatments for high-risk smoldering multiple myeloma.
The applications are based on findings from the ongoing Phase 3 AQUILA study, which is evaluating Darzalex Faspro as a monotherapy for adult patients with high-risk smoldering multiple myeloma.
Smoldering multiple myeloma, a precursor stage to active multiple myeloma, is characterised by detectable abnormal cells in the bone marrow without symptoms typically associated with active disease.
Johnson & Johnson oncology, innovative medicine global therapeutic area head Yusri Elsayed said: “There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma.
“Darzalex has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm.”
Initial data from the AQUILA study, which compares the safety and efficacy of Darzalex Faspro with active monitoring in high-risk smoldering multiple myeloma.
The AQUILA trial is a multicenter, randomised study involving 390 participants. Primary endpoints focus on progression-free survival, while secondary endpoints include time to progression, overall response rate, and overall survival.
Participants in the study were diagnosed with smoldering multiple myeloma within the last five years and were excluded if they had previously received treatment for smoldering multiple myeloma or active multiple myeloma.
Darzalex Faspro, approved by the FDA in May 2020, is authorised for nine indications in multiple myeloma, including four frontline indications for newly diagnosed patients, both transplant-eligible and ineligible.
It is the only subcutaneous CD38-directed antibody approved for multiple myeloma, formulated with recombinant human hyaluronidase PH20 (rHuPH20), an ENHANZE drug delivery technology developed by Halozyme.
Darzalex, initially approved by the FDA in November 2015, holds eight indications, with three in the frontline setting for newly diagnosed patients. The therapy is the first CD38-directed antibody approved for multiple myeloma treatment.
In a 2012 agreement, Janssen Biotech and Genmab granted the former an exclusive licence for the global development, manufacturing, and commercialisation of daratumumab.
Last month, the European Commission approved the subcutaneous formulation of Darzalex in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT).
